(139 days)
No
The summary describes a mechanical implant device for limb salvage surgery and makes no mention of software, algorithms, or any AI/ML related terms.
Yes
The device is indicated for radical resection and replacement of the proximal or total femur, which is a therapeutic intervention.
No
Explanation: The device description clearly states its purpose is to "replace the proximal femur" and "replace the entire femur," indicating it is a prosthetic implant for treatment, not a diagnostic tool for identifying a condition.
No
The device description clearly details physical components like a femoral stem, housing, neck, tibial base, etc., indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that the REPIPHYSIS Limb Salvage Proximal Femur and Total Femur are designed to replace parts of the femur (a bone in the leg). This is a surgical implant, not a device used for testing samples.
- Intended Use: The intended use is for "radical resection and replacement of the proximal or total femur." This is a surgical procedure, not a diagnostic test.
The device is a surgical implant used for limb salvage in skeletally immature patients with osteosarcoma. It is not used to diagnose a condition or test bodily samples.
N/A
Intended Use / Indications for Use
The REPIPHYSIS Limb Salvage Proximal Femur and REPIPHYSIS Limb Salvage Total Femur are indicated for cemented procedures where radical resection and replacement of the proximal or total femur is required in skeletally immature patients (weighing up to 67 lbs) with osteosarcoma.
REPIPHYSIS Limb Salvage Proximal and Total Femur devices are intended for cemented use only.
Product codes
JDI, KRO
Device Description
The REPIPHYSIS® Limb Salvage Proximal Femur is designed to replace the proximal femur with an expansion mechanism that has the identical internal components as the expansion mechanism in the previously cleared REPIPHYSIS® Limb Salvage System. The REPIPHYSIS® Limb Salvage Total Femur is designed to replace the entire femur with an expansion mechanism in the distal femoral portion that is identical to the expansion mechanism in the previously cleared REPIPHYSIS® Limb Salvage System.
REPIPHYSIS® Limb Salvage Proximal Femur
The REPIPHYSIS® Limb Salvage Proximal consists of a femoral stem, a femoral housing with expansion mechanism, and a femoral neck designed to be used with all previously cleared WMT 12/14 taper femoral heads. The components of the REPIPHYSIS® Proximal Femur are substantially equivalent to the components of the GUARDIAN™ Limb Salvage System for proximal femur replacement. The REPIPHYSIS® Limb Salvage Proximal Femur is custom assembled for each patient.
REPIPHYSIS® Limb Salvage Total Femur
The REPIPHYSIS® Limb Salvage Total Femur consists of a tibial base, axial bushing, axial pin, distal hinge femur housing with expansion mechanism, and a proximal femoral component. The components of the REPIPHYSIS® Total Femur are substantially equivalent to the components of the GUARDIAN™ Limb Salvage System for total femur replacement. The tibial base, axial bushing, axial pin, and distal hinge femur housing with expansion mechanism are identical to the components of the REPIPHYSIS® Limb Salvage System. The REPIPHY SIS® Limb Salvage Total Femur is custom assembled for each patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal or total femur
Indicated Patient Age Range
Skeletally immature patients (weighing up to 67 lbs)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
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510(K) SUMMARY JAN - 9 2008 OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the REPIPHYSIS® Limb Salvage Proximal Femur and Total Femur.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | June 27, 2007 |
| Contact Person: | Ehab Esmail |
| Director, Regulatory Affairs | |
| Proprietary Name: | REPIPHYSIS® Limb Salvage Proximal Femur and |
| Total Femur | |
| Common Name: | Limb Salvage System |
| Classification Name and Reference: | 21 CFR 888.3510 Prosthesis, Knee, Femorotibial, |
| Constrained, Cemented, Metal/Polymer - Class II | |
| 21 CFR 888.3350 Prosthesis, Hip, Semi- | |
| Constrained, Metal/Polymer Cemented- Class II | |
| Device Product Code and Panel Code: | Orthopedics/87/JDI |
| Orthopedics/87/KRO |
DEVICE INFORMATION
A. INTENDED USE
The REPIPHYSIS Limb Salvage Proximal Femur and REPIPHYSIS Limb Salvage Total Femur are indicated for cemented procedures where radical resection and replacement of the proximal or total femur is required in skeletally immature patients (weighing up to 67 lbs) with osteosarcoma.
REPIPHYSIS Limb Salvage Proximal and Total Femur devices are intended for cemented use only.
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B. DEVICE DESCRIPTION
The REPIPHYSIS® Limb Salvage Proximal Femur is designed to replace the proximal femur with an expansion mechanism that has the identical internal components as the expansion mechanism in the previously cleared REPIPHYSIS® Limb Salvage System. The REPIPHYSIS® Limb Salvage Total Femur is designed to replace the entire femur with an expansion mechanism in the distal femoral portion that is identical to the expansion mechanism in the previously cleared REPIPHYSIS® Limb Salvage System.
REPIPHYSIS® Limb Salvage Proximal Femur
The REPIPHYSIS® Limb Salvage Proximal consists of a femoral stem, a femoral housing with expansion mechanism, and a femoral neck designed to be used with all previously cleared WMT 12/14 taper femoral heads. The components of the REPIPHYSIS® Proximal Femur are substantially equivalent to the components of the GUARDIAN™ Limb Salvage System for proximal femur replacement. The REPIPHYSIS® Limb Salvage Proximal Femur is custom assembled for each patient.
REPIPHYSIS® Limb Salvage Total Femur
The REPIPHYSIS® Limb Salvage Total Femur consists of a tibial base, axial bushing, axial pin, distal hinge femur housing with expansion mechanism, and a proximal femoral component. The components of the REPIPHYSIS® Total Femur are substantially equivalent to the components of the GUARDIAN™ Limb Salvage System for total femur replacement. The tibial base, axial bushing, axial pin, and distal hinge femur housing with expansion mechanism are identical to the components of the REPIPHYSIS® Limb Salvage System. The REPIPHY SIS® Limb Salvage Total Femur is custom assembled for each patient.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The material and design features of the proposed REPIPHYSIS® Proximal Femur and Total Femur are substantially equivalent to the REPIPHYSIS® Limb Salvage System. The surgical technique and intended use for the REPIPHYSIS® Proximal Femur and Total Femur are substantially equivalent to the GUARDIAN™ Limb Salvage System. The safety and effectiveness of the REPIPHYSIS® Limb Salvage Proximal Femur and Total Femur are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular fashion around the eagle.
Public Health Service
JAN - 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wright Medical Technology, Inc. % Mr. Ehab M. Esmail Director, Regulatory Affairs 5677 Airline Road Arlington, Tennessee 38002
Re: K072367
Trade/Device Name: REPIPHYSIS® Limb Salvage System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO, JDI Dated: December 18, 2007 Received: December 28, 2007
Dear Mr. Esmail:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 – Mr. Ehab M. Esmail
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mullan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K072367
Device Name:_REPIPHYSIS® Limb Salvage System
Indications For Use:
The REPIPHYSIS Limb Salvage Proximal Femur and REPIPHYSIS Limb Salvage Total Femur are indicated for cemented procedures where radical resection and replacement of the proximal or total femur is required in skeletally immature patients (weighing up to 67 lbs) with osteosarcoma.
REPIPHYSIS Limb Salvage Proximal and Total Femur devices are intended for cemented use only.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Barbave Buehrn
Division of General, Restorative, and Neurological Devices
510(k) Number K072367